NCT01387737

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,299

participants targeted

Target at P75+ for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started May 2011

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 28, 2014

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

June 28, 2011

Results QC Date

March 26, 2014

Last Update Submit

December 15, 2025

Conditions

Type 2 Diabetes Mellitus

Keywords

TA-7284JNJ-28431754CanagliflozinSodium Glucose Co-Transporter (SGLT2 inhibitor)

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events

    54 weeks

Secondary Outcomes (4)

  • Change in HbA1c

    Week 52

  • Change in Fasting Plasma Glucose

    Week 52

  • Change in Body Weight

    Week 52

  • Change in Blood Pressure

    Week 52

Study Arms (2)

TA-7284-Low

EXPERIMENTAL
Drug: TA-7284-Low

TA-7284-High

EXPERIMENTAL
Drug: TA-7284-High

Interventions

TA-7284-LowDRUG

TA-7284-Low

TA-7284-Low
TA-7284-HighDRUG

TA-7284-High

TA-7284-High

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women age ≥20 years old
  • Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
  • HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
  • HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

You may not qualify if:

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
  • Past or current history of severe diabetic complications
  • Fasting plasma glucose \> 270 mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research site

Chugoku, Japan

Location

Research site

Hokkaido, Japan

Location

Research site

Kanto, Japan

Location

Research site

Kinki, Japan

Location

Research site

Kyushu, Japan

Location

Research site

Shikoku, Japan

Location

Research site

Tōhoku, Japan

Location

Related Publications (2)

  • Inagaki N, Goda M, Yokota S, Maruyama N, Iijima H. Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 3.

    PMID: 26530268DERIVED

  • Inagaki N, Kondo K, Yoshinari T, Kuki H. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study. J Diabetes Investig. 2015 Mar;6(2):210-8. doi: 10.1111/jdi.12266. Epub 2014 Aug 25.

    PMID: 25802729DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Nobuya Inagaki, M.D.

    Kyoto University, Graduate School of Medicine

    STUDY DIRECTOR

  • Kazuoki Kondo, M.D.

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

July 6, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

January 8, 2026

Results First Posted

April 28, 2014

Record last verified: 2025-12

Locations

JP(7)